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U.S. Department of Health and Human Services

Class 2 Device Recall P.F.C.

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  Class 2 Device Recall P.F.C. see related information
Date Initiated by Firm May 26, 2005
Date Posted August 12, 2005
Recall Status1 Terminated 3 on December 02, 2005
Recall Number Z-1187-05
Recall Event ID 32192
510(K)Number K033272  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015.
Code Information Lots Y58F14 and YY5BH4. 
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-366-8143
Manufacturer Reason
for Recall		 An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
FDA Determined
Cause 2		 Other
Quantity in Commerce 18
Distribution Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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